Tenofovir Alafenamide Switching Therapy in Kidney or Liver Transplant Recipients with Chronic HBV Infection

Phase 4

Active, not recruiting

• Conditions: Safety Issues; Chronic Hepatitis B; Transplant Recipient
• Interventions: Drug: Tenofovir Alafenamide 25 MG

• Registration Number: NCT05410496
• Lead Sponsor: Taichung Veterans General Hospital

Brief Summary

tenofovir alafenamide (TAF) has been approved to be highly effective and safe in patients with chronic hepatitis B (CHB), therefore TAF may be a good option in kidney or liver transplant patients with chronic HBV infection. The aim of this prospective cohort study is to assess the safety, efficacy, and drug adherence improvement of TAF switching therapy in kidney or liver transplant patients with HBV infection.

Detailed Description

Life-long nucleos(t)ide analogue (NA) therapy has been recommended in patients with chronic HBV infection after organ transplantation, therefore the safety of long-term NA therapy is particularly important in transplant patients. Entecavir, tenofovir disoproxil fumarate (TDF), and tenofovir alafenamide (TAF) are recommended drugs for CHB patients in current guidelines because of their high potency in antiviral efficacy and low rate in virological resistance. However, the data of TAF therapy in transplant patients remain limited.

The potential nephrotoxicity and a decrease in bone mineral density (BMD) of TDF therapy have been reported in previous studies. TAF is a novel prodrug of tenofovir and is formulated to deliver the active metabolite to target cells more efficiently than TDF at a much lower dose, thereby reducing systemic exposure to tenofovir. In the randomized controlled trials of TDF versus TAF showed that virological and serological results were similar in both arms. However, patients in TAF arm had improved renal effects and BMD as compared to TDF. Improvement in renal function and BMD were also found in chronic hepatitis B patients who switched from TDF to TAF. Furthermore, in some retrospective studies, switching from entecavir to TAF may present a superior efficacy in HBV DNA suppression and HBsAg level reduction, and renal safety was comparable between the TAF switch group and the entecavir continuation group. Interestingly, switching from entecavir to TAF is associated with improvement of the medication adherence, which may be particularly important to patients under long-term NA therapy.

The clinical data of TAF therapy in transplant patients remain very limited, particularly in kidney transplant patients. With a high virological response rate and a low adverse effect (AE) rate in patients with CHB, TAF may be a good option for patients underwent liver or kidney transplantation.The aim of this study is to assess the safety, drug adherence, and efficacy of TAF switching therapy in kidney or liver or transplant patients with chronic HBV infection.

Study Timeline

• Study Start: 2021-06-22
• Study First Submitted: 2022-05-13
• Study First Submitted QC: 2022-06-06
• Study First Posted: 2022-06-08
• Primary Completion: 2024-07-30
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-07
• Last Update Posted: 2025-01-09
• Study Completion: 2027-07-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

1. At least 20 years of age
2. Chronic HBV infection under NA therapy other than TAF
3. Underwent kidney and/ or liver transplantation
4. Without clinical or pathologic evidence of moderate or severe rejection
5. Patients who are indicated for TAF switching therapy, such as concerns in virological response, biochemical response, drug compliance, or safety issues to other NAs.

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Exclusion Criteria

1. End stage renal disease (eGFR < 15 mL/min/1.73m2)
2. Co-infected with human immunodeficiency virus (HIV) or hepatitis C virus (HCV)
3. Any active malignancies
4. Pregnant or breast-feeding women
5. Known allergy to tenofovir-contained regimens

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TAF switching therapy cohort	Tenofovir Alafenamide 25 MG	A prospective single-arm cohort to evaluate the safety, drug adherence, and efficacy of TAF switching therapy in kidney or liver or transplant patients with chronic HBV infection.

Primary Outcome Measures

Name	Time	Method
Estimated glomerular filtration rate	week 48	0-120 ml/min/1.73m2 (higher scores mean a better outcome)
HBV viral load	week 48	0-8 log10 IU/mL; blood HBV DNA level (higher scores mean a worse outcome)
Drug adherence score	week 48 (higher scores mean a better outcome)	Score 1-8; Morisky Medication Adherence Scale-8 questionnaire

Secondary Outcome Measures

Name	Time	Method
Estimated glomerular filtration rate	week 144	0-120 ml/min/1.73m2 (higher scores mean a better outcome)
HBV viral load	week 144	0-8 log10 IU/mL; blood HBV DNA level (higher scores mean a worse outcome)
Drug adherence score	week 144 (higher scores mean a better outcome)	Score 1-8; Morisky Medication Adherence Scale-8 questionnaire
Bone mineral density	week 144	0-5 g/cm2; dual-energy X-ray absorptiometry (higher scores mean a better outcome)
Alanine aminotransferase	week 144	0-150000 IU/mL; blood ALT level (higher scores mean a worse outcome)
Quantitative HBsAg	week 144	0-10000 IU/mL; blood qHBsAg level (higher scores mean a worse outcome)
Liver fibrosis elastography	week 144	0-30 kPa; ultrasound elastography (higher scores mean a worse outcome)

Trial Locations

Locations (2)

China Medical University Hospital; 🇨🇳 Taichung, Taiwan

Taichung Veterans General Hospital; 🇨🇳 Taichung, Taiwan